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JC-Virus (JCV) Antibody Program (STRATIFY-1)

This study has been completed.
Sponsor:
Collaborators:
United BioSource Corporation
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01070823
First received: February 17, 2010
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.


Condition Intervention
Multiple Sclerosis
Drug: Tysabri® (natalizumab)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Prevalence of serum anti-JC virus (JCV) antibody [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Prevalence of anti-JCV antibodies will be estimated as the number of participants with anti-JCV antibodies detected in serum divided by the total number of participants with a serum sample that was evaluated.

  • Number of participants with a false negative test [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Confirm the false negative rate for serum anti-JCV antibody [assay].


Secondary Outcome Measures:
  • Changes in JCV antibody status over time [ Time Frame: Every 6 months for 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum, Urine and Plasma


Enrollment: 1096
Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Relapsing Multiple Sclerosis
Participants receiving or considering treatment with Tysabri® (natalizumab).
Drug: Tysabri® (natalizumab)
Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program
Other Names:
  • natalizumab
  • BG0002

Detailed Description:

This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with relapsing Multiple Sclerosis (MS) receiving commercial Tysabri® (natalizumab) and patients being considered for such treatment.

Criteria

Key Inclusion Criteria:

  • Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab).

Key Exclusion Criteria:

  • Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070823

Locations
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30327
Research Site
Cullman, Georgia, United States, 35058
United States, Illinois
Research Site
Barrington, Illinois, United States, 60010
United States, Massachusetts
Research Site
Brighton, Massachusetts, United States, 2135
United States, Michigan
Research Site
Farmington Hills, Michigan, United States, 48334
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27607
United States, Oregon
Research Site
Portland, Oregon, United States, 97225
United States, Texas
Research Site
Round Rock, Texas, United States, 78681
United States, Utah
Research Site
Salt Lake City, Utah, United States
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Biogen Idec
United BioSource Corporation
Elan Pharmaceuticals
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01070823     History of Changes
Other Study ID Numbers: 101JC401
Study First Received: February 17, 2010
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Sample Collection
JCV
PML

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014